Adverse Drug Events Increase: Do the Benefits Outweigh the Risks?

Imagine someone being prescribed a drug that was approved by the FDA and their doctor. They would hope that the drug would alleviate their illness in some form or fashion. However, contrary to what we may expect, certain prescription drugs may cause adverse events, such as hospitalization or even death. What is worse is that warning of these adverse events may not even be included with the prescription. One study recently concluded that there has been an increase in the number of reported deaths and injuries associated with drug therapy. As I researched this topic more I discovered two quite insightful blogs challenging the key findings of this study. The first post I examined was from Furious Seasons, written by Philip Dawdy, a skeptical journalist suffering from bipolar disorder. This post lays the blame on the FDA, doctors and the media for not doing anything to bring more light to the issue of adverse drug events. The second post comes from a blog titled Clinical Psychology and Psychiatry: a Closer Look. Here, the author, “an academic with a respectable amount of clinical experience,” explores how clinical trials do a poor job of reporting drug safety outcomes. My comments to both these blogs, which can be found below and by following the links above, mainly focus on how some people may negatively react as a result of this increase in reported adverse drug events.

“Worse Than Vioxx: Zyprexa, Risperdal, Clozaril, And Paxil Killed Thousands of Americans” comment:
I agree with a lot of what you had to say on this topic. The media should really step it up and bring more light to such issues on reported adverse events. This, in turn, would increase public awareness. However, I could not help but wonder if more media coverage on these drug related deaths would ultimately lead patients to experience feelings of betrayal and mistrust toward their health care providers. In other words, patients being handed prescriptions will no longer trust the doctors issuing them. This might even cause them to avoid seeking treatment for their illness or deny drug therapy altogether. It hurt me most to hear that “Risperdal, a drug associated with over 1,000 deaths, is used in children--and the FDA approved its use”. How can drugs such as this one (see image above), used to treat schizophrenia, continue to be prescribed? It might be true that this drug has helped many. But, the FDA has to ask itself the pressing question: do the benefits outweigh the serious risks. I believe that risks such as death and disability outweigh the benefits. More research needs to be conducted on these drugs, in order to properly label all the side effects and to determine whether it is best to simply take the drugs off the market as was the case with Vioxx.

“The Drug Safety Blindfold” comment:
When I first read this study, one of the things that immediately caught my attention was the limitation that states that the submission of an adverse event does not establish causality. An adverse drug event could be reported by anyone who felt that there was a relationship between their drug and their adverse event. Right away this signaled to me that more research is needed to be sure that these adverse events are in fact being caused by the prescription drugs. I quickly visited the FDA MedWatch website and noticed how easy it was to submit a report. The reporting system should be altered, so that opinions from second sources such as health care providers can confirm suspected relationship with the drug. I agreed with Furious Seasons’ post that the media and the FDA need to further inform the public about the serious risks their prescription drugs may elicit, but I also feel that it is essential that more research be conducted first. Bringing too much attention to these pre-mature findings could lead many people to feel trepidation when taking their drugs or may lead them to report more and more serious injuries that may not even be related to the drug effects.